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510(k) K952038

CLEAN-CUFF by Instrumed, Inc. — Product Code KCY

K952038 is an FDA 510(k) premarket notification submitted by Instrumed, Inc. for the device "CLEAN-CUFF". The FDA issued a decision of Substantially Equivalent on July 11, 1995. The device falls under product code KCY (Tourniquet, Pneumatic), a Class I device regulated under 21 CFR 878.5910. Instrumed, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1995
Date Received
May 1, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tourniquet, Pneumatic
Device Class
Class I
Regulation Number
878.5910
Review Panel
SU
Submission Type

Other clearances by Instrumed, Inc.

  • K940615 — ACCUTEST (May 19, 1995)
  • K924273 — ACCUFLATE (January 12, 1993)
  • K924373 — ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMP (November 25, 1992)
  • K910512 — ACCUFLATE (February 19, 1991)
  • K890014 — DISPOSABLE COLOR-CUFFS (January 24, 1989)
  • K860617 — POLYPET (March 3, 1986)

Other clearances for product code KCY

  • K202919 — ATS 5000 Automatic Tourniquet Instrument (May 20, 2021)
  • K162365 — T-Cuff (February 16, 2017)
  • K123553 — ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM (August 9, 2013)
  • K112874 — EZ VEIN INFLATABLE TOURNIQUET (October 17, 2011)
  • K071140 — MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002 (June 7, 2007)
  • K050411 — ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM (September 2, 2005)
  • K012632 — TOURNIQUET CUFF; PNEUMATIC TOURNIQUET (October 26, 2001)
  • K955552 — EXPRESSAIRE TORUNIQUET SYSTEM (January 5, 1996)
  • K954201 — BUONAFEDE PNEUMATIC SLEEVE (November 9, 1995)
  • K954103 — TOURNI-COMP (November 1, 1995)

FDA data resources